Provision on Quality Management System of the Federal Environmental, Industrial and Nuclear Supervision Service in the Field of State Regulation of Safety at Atomic Energy Use

I. General provisions

1. The present Provision on quality management system of the Federal Environmental, Industrial and Nuclear Supervision Service in the field of state regulation of safety at atomic energy use (hereinafter referred to as the Provision) is developed taking into account:

1)  “National Policy Fundamentals in the Field of Nuclear and Radiation Safety of the Russian Federation for the Period up to 2025” enacted by the President of the Russian Federation No.Pr-539 dated of March 1, 2012;

2) “Provisions on Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the RF Government Decree No.401 dated of July 30, 2004;

3) The requirements of regulatory legal acts of the Federal Environmental, Industrial and Nuclear Supervision Service. 

2. The Provision took into account the recommendations from the documents of the Western European Nuclear Regulators Association (WENRA), IAEA (including the IAEA Safety Requirements No.GS-R-3 “The Management System for Facilities and Activities”, the IAEA Safety Guide No.GS-G-3.1 “Application of the Management System for Facilities and Activities”), as well as the provisions stipulated by GOST ISO 9001-2011 “Quality Management System. Requirements”.

3. The present Provision covers the activity performed by the staff of the following structural departments of Rostechnadzor:

1)           Department for Safety Regulation of Nuclear Plants and Research Nuclear Installations;

2)           Department for Safety Regulation of Nuclear Fuel Cycle Facilities, Nuclear Power Installations of Vessels and Radiation Hazardous Facilities; 

3)           Department of State Construction Supervision;

4)           Department of Special Security;

5)           Structural departments of Rostechnadzor’s Headquarters, which cooperate with the structural departments mentioned in sub-paragraphs 1 – 4 of this paragraph (including the Administration Department, Department for Support of Organizational and Control & Licensing and Authorizing Activities, Department of Finance, Department of State Service and Staffing, Legal Department);

6)           Rostechnadzor’s interregional territorial departments for supervision over nuclear and radiation safety.

4. Rostechnadzor’s Quality Management System (hereinafter to be referred to as QMS) incorporates QMSs of Rostechnadzor’s interregional territorial departments for supervision over nuclear and radiation safety, as well as QMSs of subordinating scientific and technical support organizations.

5. Rostechnadzor’s QMS aims at continuous improvement of Rostechnadzor’s activity, when Rostechnadzor exercises its powers related to state supervision of safety at atomic energy use, as well as monitoring, analysis, management of current and planned processes. QMS is implemented by means of: 

1) provision of the common understanding of the key-aspects of safety culture  applied in the system of Rostechnadzor; 

2) establishment of requirements for Rostechnadzor’s staff and provision of conditions, required for successful implementation of the assigned official duties;

3) promotion of constructive and critical attitude of Rostechnadzor staff towards provision of adequate quality of work during their implementation of official duties.

6. QMS structure includes the following processes:

1) basic processes: 

a)           “Legal regulation of safety in the field of use of atomic energy”;

b)          “Licensing (authorizing) activity in the field of use of atomic energy”;

c)           “Federal state supervision in the field of atomic energy use”;

d)          “International cooperation with regard to issues of nuclear and radiation safety regulation at atomic energy use”. 

2) management processes:

a)           “Human resources management”;

b)          “Review of QMS”.

3) supporting processes:

a)           “Production of scientific and technical products”;

b)          “Documentation management”.

 

The model of the system of processes in frames of QMS is given as an appendix herein.

 

7. QMS fundamental principles are as follows:

1) enhancement and improvement of effectiveness of the state policy and regulatory and legal framework within the limits of the established sphere of activity; 

2) separation of jurisdictions between Rostechnadzor, other authorities for state regulation of safety at atomic energy use and organizations the activity of which deals with atomic energy use;

3) Rostechnadzor interaction with other state authorities for regulation of safety at atomic energy use, bodies for control over atomic energy use, as well as with the federal executive bodies;

4) inadmissibility for Rostechnadzor in the course of state regulation of safety in the field of atomic energy use to restrict unreasonably activities of operating and other organizations that are performing works and rendering services in the field of atomic energy use; 

5) application of a graded approach to selection of scopes and forms of the state regulation of safety in the course of atomic energy use depending on the potential danger and safety state of nuclear facilities; 

6) provision of transparency of activity on regulation of safety безопасности on the basis of accessibility of information about the safety state of nuclear facilities and Rostechnadzor’s activity (except for information considered to be the state secret or secret to be secured by the legislation of the Russian Federation);

7) provision of the adequate quality of the regulatory activity by good faith fulfillment of obligations and office duties by all employees of Rostechnadzor;

8) liability of the executors for the quality of implementation of the nuclear facility safety regulation functions imposed on them;

9) observance of professional standards of ethics and business behavior rules by all employees of Rostechnadzor;

10) provision by all-levels management staff and within the limits of their competence of planning of activity  that envisages adequate preparation to works’ implementation, allocation of responsibilities and periodic reporting about works performed and with analysis of these works results;

11) encouragement of employees, who take active part in applying and enhancement of QMS, by the Chairman of Rostechnadzor in compliance with the established procedure.

 

II. Basic processes of QMS

8. In frames of the process “Legal regulation of safety in the field of use of atomic energy” the following actions are to be carried out:

1) participation in development and concurrence of legislative and regulatory legal acts of the Russian Federation;

2) development and adoption of regulatory legal acts of Rostechnadzor (or amendment of the effective regulatory legal acts of Rostechnadzor), including:

a) federal regulations in the field of atomic energy use in accordance with the legislation of the Russian Federation;

b) administrative regulations for execution of state functions by Rostechnadzor (rendering state services);

c) other regulatory legal acts within the established field of activities in compliance with the “Provision on the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the RF Government Decree No.401 dated of July 30, 2004;

3) development, approval and putting into effect of safety guides at atomic energy use.

8.1. The process main results are as follows:

1) development of substantiated requirements to nuclear facility safety and to activities in the field of atomic energy use;

2) timeliness of adoption of the required measures for provision of the effective state policy and enhancement of legal and regulatory framework based on the analysis of national and foreign practice in regulatory activity in the field of atomic energy use;

3) development and adoption of regulatory legal acts and safety guides, containing the procedures for implementation of Rostechnadzor’s imposed tasks, functions and authorities.

8.2. The procedure of the process implementation is stipulated by the following acts:

1) The Federal Law No.170-FZ “On the Use of Atomic Energy” dated of November 21, 1995;

2) The Decree of the President of the Russian Federation No.780 “Issues Related to the Federal Environmental, Industrial and Nuclear Supervision Service” dated of June 23, 2010;

3) “Provision on Monitoring over Law Enforcement in the Russian Federation” enacted by the Decree of the President of the Russian Federation No.657 dated of May 20, 2011;

4) “Rules for Development of Regulatory Legal Acts of Federal Executive Bodies and State Registration Thereof” enacted by the RF Government Decree No.1009 dated of August 13, 1997;

5) “Provision on Development and Approval of the Federal Regulations in the Field of Use of ATOMIC Energy” enacted by the RF Government Decree No.1511 dated December 1, 1997;

6) The RF Government Decree No.260 dated of June 1, 2004 “About Regulations of the Government of the Russian Federation and Provision on the Executive Office of the Government of the Russian Federation”;

7) “Rules for Conduct of Anti-Corruption Review of Regulatory Legal Acts and Drafts of Regulatory Legal Acts” enacted by the RF Government Decree No.96 dated of February 26, 2010;

8) “Methodology for Monitoring over Law Enforcement in the Russian Federation” enacted by the RF Government Decree No.694 dated of August 19, 2011;

9) “Rules for Development and Approval of Administrative Regulations for Execution of the State Functions”; “Rules for Development and Approval of Administrative Regulations for Rendering of the State Services”; “Rules for Conduct of the Review of Draft Administrative Regulations for Rendering of the State Services” enacted by the RF Government Decree No.373 dated of May 16, 2011;

10) “Rules for Disclosure by the Federal Executive Bodies of Information about Drafting of Regulatory Legal Acts and the Results of Public Hearings” enacted by the RF Government Decree No.851 dated of August 25, 2012;

11) “Rules for Evaluation by the Federal Executive Bodies of the Regulatory Impact of the Draft Regulatory Legal Acts, Draft Amendments to the Draft Federal Laws and Drafts of Decisions of the Council of the Eurasian Economic Commission” enacted by the RF Government Decree No.1318 dated of December 17, 2012;

12) “Procedure for Publication and Putting into Effect of the Acts of the Federal Environmental, Industrial and Nuclear Supervision Service, Recognized by the Ministry of Justice of the Russian Federation and not Subject to the State Registration” enacted by Rostechnadzor’s Order No.1039 dated of November 11, 2010;

13) “Procedure for Development of Federal Regulations in the Field of Atomic Energy Use in the Federal Environmental, Industrial and Nuclear Supervision Service and Requirements to their Format and Content” enacted by the Rostechnadzor’s Order No.27 dated of January 24, 2011;

14) “Provision on the Procedure of Development of Safety Guides at Atomic Energy Use, their Approval, Putting into Effect and Amendment thereof” enacted by the Rostechnadzor’s Order No.752 dated of December 21, 2012.

9. In frames of the process “Licensing (authorizing) activity in the field of use of atomic energy” the following actions are to be performed:

1) granting of a right to operating organizations as well as to the organizations performing works and rendering services in the field of atomic energy use for implementation of a certain type of activity on condition the safety of a nuclear facility and works performed (services rendered) is ensured by means of issuing a license for implementation of activity in the field of atomic energy use;

2) granting of a right to perform works in the field of atomic energy use to nuclear facility personnel;

3) issuing of permits for discharges and emissions of radioactive substances into the environment;

4) establishing values of maximum allowable emissions of radioactive substances into the atmosphere and maximum allowable discharges of radioactive substances into water bodies.

9.1. The main results of the process include as follows:

1) prior to issuing a license and/or permits, and/or establishing of limit values:

a) provision of completeness of analysis for compliance of the submitted package of documents with the established requirements; 

b) provision of objectiveness of the comprehensive validation of data, presented in the Applicant’s documents;

2) upon issuing of licenses and/or permits, and/or establishing of limit values:

a) provision of completeness of analysis for meeting the license and/or permit conditions;

b) provision of the completeness of analysis for meeting the safety requirements of a nuclear facility.

9.2. The following acts identify procedure for this process performance:

1) The Federal Law No.170-FZ “On the Use of Atomic Energy” dated of November 21, 1995;

2) “List of Job Positions of Nuclear Facility Employees, which are to Obtain Licenses of the Federal Environmental, Industrial and Nuclear Supervision Service Granting a Right for Performance of Works in the Field of Atomic Energy Use” enacted by the RF Government Decree No.240 dated of March 3, 1997;

3) The RF Government Decree No.233 “On the List of Medical Contraindications and the List of Job Positions subject to these Contraindications, as well as on the Requirements to Conduct of Medical Examinations and Psychophysiological Surveys of Nuclear Facility Employees” dated of March 1, 1997;

4) “Provisions on Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the RF Government Decree No.401 dated of July 30, 2004;

5) “Provision on Licensing of Activities in the Field of Atomic Energy Use” enacted by the RF Government Decree No.280 dated of March 29, 2013;

6) “Administrative Regulations for Execution by the Federal Environmental, Industrial and Nuclear Supervision Service of the State Function on Licensing of Activities in the Field of Atomic Energy Use” enacted by the Order of the Ministry of Natural Resources and Environment of the Russian Federation No.262dated of October 16, 2008;

7) “Administrative Regulations for Rendering by the Federal Environmental, Industrial and Nuclear Supervision Service of the State Service on Issuing Permits to Grant the Right to Employees of Nuclear Facilities” enacted by the Rostechnadzor Order No.721 of December 21, 2011; 

8) “Administrative Regulations for Rendering by the Federal Environmental, Industrial and Nuclear Supervision Service of the State Services on Establishing of Limit Values for Maximum Allowable Emissions of Radioactive Substances into Atmosphere and Maximum Allowable Discharges of Radioactive Substances into Water Bodies, for Issuing of Permits on Emissions and Discharges of Radioactive Substances into the Environment” enacted by the Rostechnadzor Order No.594 dated of October 19, 2012;

9) Rostechnadzor Order No.179 dated of April 24, 2013 “On Implementation of the Provisions on Licensing of Activities in the Field of Atomic Energy Use” enacted by the RF Government Decree No.280 dated of March 29, 2013.

10. In frames of the process “Federal state supervision in the field of atomic energy use” the following actions are to be performed:

1) systematic supervision over fulfillment of requirements stipulated by the federal laws and other regulatory legal acts of the Russian Federation (hereinafter to be referred to as mandatory requirements) in the field of atomic energy use by legal entities, their leadership and other job positions, over adherence to permit (license) conditions granting the right for performance of works in the field of atomic energy use (hereinafter to be referred to as license conditions), as well as analysis and prediction of the progress of fulfillment of mandatory requirements and license conditions at implementation of activities in the field of atomic energy use by supervised individuals;

2) arrangement and procedure of conduct of checks (inspections) regarding fulfillment by the supervised individuals of mandatory requirements, adherence to permit (license) conditions, meeting of limit values established for discharges and emissions of radioactive substances into the environment, as well as execution of Rostechnadzor’s orders;

3) taking of response measures envisaged in the RF legislation in case of detection of violations of mandatory requirements and license (permit) conditions;

4) execution of the permanent state supervision at nuclear facilities.

10.1. The main results of the process are as follows:

1) safety assessment of a nuclear facility state, as well as evaluation and prediction of fulfillment of the mandatory requirements at performance of activities in the field of atomic energy use;

2) documenting of an act of check (inspection) or record in the permanent state supervision records log;

3) issuing of prescriptions for elimination of the detected violations to the mandatory requirements indicating the time period for elimination thereof;

4) taking measures on suppression of the detected violations envisaged by the RF legislation with regard to supervision over elimination of the detected violations, prevention thereof, prevention of potential damages, prevention of natural and man-induced emergencies, as well as measures on bringing individuals, who committed the detected violations, to responsibility;

5) suspension or termination of licenses (permits) issued by Rostechnadzor granting the right to perform works in the field of atomic energy use.

10.2. The following acts specify the procedure for the process implementation:

1) The Federal Law No.170-FZ “On the Use of Atomic Energy” dated of November 21, 1995; 

2) The Federal Law No.195-FZ “Code of the Russian Federation on Administrative Violations” dated of December 30, 2001;

3) The Federal Law No.190-FZ “Urban Development Code of the Russian Federation” dated of December 29, 2004;

4) The Federal Law No.294-FZ “On Protection of Rights of Legal Entities and Individual Entrepreneurs in the Course of Governmental and Municipal Supervision” dated of December 26, 2008;

5) The Federal Law No.384-FZ “Technical Regulations on Safety of Buildings and Structures” dated of December 30, 2009;

6) “Provision on Monitoring over Law Enforcement in the Russian Federation” enacted by the Decree of the President of the Russian Federation No.657 dated of May 20, 2011;

7) “Provisions on Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the RF Government Decree No.401 dated of July 30, 2004;

8) “Provision on State Construction Supervision in the Russian Federation” enacted by the RF Government Decree No.54 dated of February 1, 2006;

9) “Methodology for Monitoring over Law Enforcement in the Russian Federation” enacted by the RF Government Decree No.694 dated of August 19, 2011;

10) “Provision on the Federal State Supervision in the Field of Atomic Energy Use” enacted by the RF Government Decree No.1044 f=dated of October 15, 2012;

11) “Provision on the Regime of Permanent State Supervision at Nuclear Facilities” enacted by the RF Government Decree No.373 dated of April 23, 2012;

12) “List of Nuclear Facilities Subject to Permanent State Supervision” enacted by the RF Government Decree No.610-r dated of April 23, 2012;

13) “Procedure for Conduct of Inspections in the Course of State Construction Supervision and Issuing of Conformance Reports for Constructed, Reconstructed, Repaired Capital Construction Facilities with the Requirements of Technical Regulations, Other Regulatory Legal Acts and Design Documentation” enacted by Rostechnadzor Order No.1129 dated of December 26, 2006;

14) “Procedure for Compilation and Maintaining of Files at State Construction Supervision” enacted by Rostechnadzor Order No.1130 dated of December 26, 2006;

15) “Procedure for Keeping of the General and(or) Special Logbook for Accounting of Works Performed at Construction, Reconstruction, Repair of Capital Construction Facilities” enacted by Rostechnadzor Order No.7 dated of January 12, 2007;

16) “Provision on Supervision over the State System of Accounting and Control of Radioactive Substances and Radioactive Materials” enacted by Rostechnadzor Order No. 323 dated of May 10, 2007;

17) “Provision on the Procedure of Organization and Conduct of Supervision over the State System of Accounting and Control of Nuclear Materials” enacted by Minprirody Order No.429 dated of December 10, 2009;

18) “Administrative Regulations for Execution by the Federal Environmental, Industrial and Nuclear Supervision Service of Functions on Control and Supervision over Physical Protection of Nuclear Installations, Radiation Sources, Storage Facilities, Nuclear Materials and Radioactive Substances over the Systems of the Unified State Accounting and Control of Nuclear Materials, Radioactive Substances, Radioactive Wastes” enacted by Rostechnadzor Order No.703 dated of December 15, 2011;

19) “Administrative Regulations on Execution by the Federal Environmental, Industrial and Nuclear Supervision Service of Functions on the Federal State Supervision in the Field of Atomic Energy Use” enacted by Rostechnadzor Order No.248 dated of June 7, 2013;

20) “ Administrative Regulations on Execution by the Federal Environmental, Industrial and Nuclear Supervision Service of the State Function on Federal State Construction Supervision at Construction, Reconstruction of Capital Construction Facilities, Specified in Item 5.1 of Article 6 of the Urban Development Code of the Russian Federation, Except for the Facilities, which are by the Decrees of the President of the Russian Federation Subject to State Construction Supervision of other Federal Executive Bodies” enacted by Rostechnadzor Order No.38 dated of January 31, 2013;

21) Instructions, methods, methodical guidelines (recommendations) enacted by Rostechnadzor’s Orders on the procedure of execution of different directions of supervision (including standard programs for conduct of checks (inspections)), as well as analysis, evaluation and prediction of the progress of meeting the mandatory requirements and license conditions at implementation of activities in the field of atomic energy use.

11. In frames of the process “International cooperation with regard to issues of nuclear and radiation safety regulation at atomic energy use” control and supervision over implementation of international obligations of the Russian Federations in the field of safety assurance at atomic energy peaceful use, interaction with government bodies of foreign states and international organizations in the specified field of activity, are performed including:

1) arrangement of fulfillment by Rostechnadzor in frames of their competence of obligations resulting from participation of the Russian Federation in international conventions, multilateral and bilateral international treaties and intergovernmental programs in the field of safety assurance at atomic energy peaceful use;

2) participation in preparation of the Russian National Reports on Fulfillment of Obligations, resulting from the provisions of the Convention on Nuclear Safety and the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management;

3) arrangement and coordination of cooperation with the governmental bodies of foreign states and international organizations on safety issues at atomic energy peaceful use, participation in international conferences and symposia conducted under the auspices of the IAEA, as well as in the events held in frames of regional and interregional projects of the IAEA Technical Cooperation Programme;

4) rendering assistance in development of the national systems of nuclear and radiation safety regulation at atomic energy peaceful use in the states, which are customers of nuclear facilities construction under Russian designs;

5) arrangement of official business trips abroad for Rostechnadzor’s staff;

6) arrangement of reception of foreign delegations and individuals at Rostechnadzor.

11.1. The process main results include implementation of the yearly international cooperation plans of Rostechnadzor.

11.2. The process procedure is specified by: 

1) the international conventions:

a) “Convention on the Physical Protection of Nuclear Material” of 1979 (with the “Amendment to the Convention on the Physical Protection of Nuclear Material” of 2005); 

b) “Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency” of 1986;

c) “Convention on Early Notification of a Nuclear Accident” of 1986;

d) “Convention on Environmental Impact Assessment in a Transboundary Context” of 1991;

e) “Convention on Nuclear Safety” of 1994; 

f) “Convention on Civil Liability for Nuclear Damage” of 1997; 

g) “Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management” of 1997;

h) “Code of Conduct on the Safety and Security of Radioactive Sources” of 2003, IAEA;

i) “Code of Conduct on the Safety of Research Reactors” of 2004, IAEA;

2) the regulatory legal acts of the Russian Federation:

a) The Federal Law No.170-FZ “On the Use of Atomic Energy” dated of November 21, 1995; 

b) The Federal Law No.101-FZ “On the International Treaties of the Russian Federation” dated of July 15, 1995;

c) “Provisions on Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the RF Government Decree No.401 dated of July 30, 2004;

d) The RF Government Decree No.339 dated of April 15, 2014 “On Cooperation on Issues Related to Development of National Regulatory Frameworks for Nuclear and Radiation Safety at Atomic Energy Peaceful Use in the States, which are Customers for Construction of Nuclear Facilities According to Russian Designs”;

3) the documents of Rostechnadzor:

a) “Procedural Guidelines on the Procedure of Preparation to and Submission of Plans and Reports in the Field of International Cooperation of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.349 dated of June 2, 2005; 

b) “Instructions on the Procedure of Sending Abroad of the Staff of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.1170 dated of December 23, 2010;

c) “ Instructions on the Procedure of Reception of Foreign Delegations and Individuals at the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.1171 dated of December 23, 2010; 

d) “Procedure and Conditions of Deputation of the Federal State Officers of the Federal Environmental, Industrial and Nuclear Supervision Service” ” enacted by the Rostechnadzor Order No.344 dated of June 19, 2012.

 

III. Management processes of QMS

12. In frames of the process “Human resources management” the following actions are performed:

1) provision of number and qualification of Rostechnadzor’s staff at the level necessary and sufficient for achievement of the goal stipulated by the Quality Policy by means of staff recruitment, certification, proficiency maintaining and development  (also by means of continuing professional education in compliance with the individual plans for professional development of Rostechnadzor’s staff, participation in seminars, meetings and conferences);

2) provision of adequate conditions for state regulation of safety at atomic energy use by Rostechnadzor, which include the provision of staff with necessary documentation, computer technologies and office equipment, industrial gages, communication means, fire safety means, vehicles, well-minded work places, as well as provision of necessary sanitary-hygienic conditions (with the account of radiation safety, noise level, vibration, temperature, humidity, lighting, electromagnetic emission and etc.);

3) evaluation of the professional service activity of Rostechnadzor’s staff.

12.1. The process main results include as follows:

1) staffing level and unavailability of professional staff flow;

2) compliance of staff qualification with the established requirements;

3) adherence to the plans on staff recruitment, training, continuing professional education and certification; 

4) provision with material, technical, financial and information resources in accordance with the planned needs.

12.2. The procedure for the process implementation is specified by:

1) The Federal Law No.79-FZ “On the State Civil Service in the Russian Federation” dated of July 27, 2004;

2) “Provision on Certification of the State Civil Officers of the Russian Federation” enacted by the Decree of the President of the Russian Federation No.110 dated of February 1, 2005;

3) “Methodological Recommendations on Establishment of the Number of Staff for the Supervision and Inspection Divisions of the Interregional Territorial Departments for Supervision over Nuclear and Radiation Safety of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.398 dated of June 10, 2008;

4) The Rostechnadzor Order No.784 “On the Authority’s Awards of the Federal Environmental, Industrial and Nuclear Supervision Service” dated of September 9, 2009;

5) “Temporary Procedure for Buildup of the Candidate Pool of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.395 dated of May 13, 2009;

6) “Regulations of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.271 dated of June 1, 2011;

7) “Code of Ethics and Conduct of the State Officers of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.328 dated of June 28, 2011;

8) “Provision on the Honors Board of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.133 dated of February 29, 2012;

9) “Exemplary Job Regulations for the Job Positions of the Federal State Civil Officers of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.260 dated of April 20, 2012;

10) “Qualification Requirements to Professional Knowledge and Skills Required for Execution of Job Duties by the Federal State Civil Officers of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.229 dated of April 4, 2012;

11) “Procedure for Approval of Individual Professional Development Plans for the Federal State Civil Officers of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.376 dated of June 29, 2012;

12) “List of Job Positions of the Federal State Civil Service in the Federal Environmental, Industrial and Nuclear Supervision Service Subject to Rotation of the Federal State Officers” enacted by the Rostechandzor Order No.651 dated of November 9, 2012.

13. In frames of the process “Review of QMS” the effectiveness of QMS is to be evaluated and subjected to further enhancement.

13.1. The main results of the process include as follows:

1) development of the certain measures based on the detailed analysis to enhance the executed activity by the leadership of the structural departments and subordinate organizations of Rostechnadzor;

2) unavailability of repeated non-conformances detected as a result of the previous reviews of the QMS.

13.2. QMS enhancement is ensured by means of:

1) periodical performance of the QMS analysis by the leadership of Rostechnadzor and determination of ways for its further enhancement; 

2) development and conduct of the corrective and preventive measures based on the results of the QMS analysis;

3) supervision over QMS enhancement measures up to their accomplishment and evaluation of the effectiveness thereof in the course of the following QMS reviews;

4) conduct under the established periodicity of internal and external supervision over implementation of the QMS fundamental principles and procedures.

 

IV. Supporting processes of QMS

14. In frames of the process “Production of scientific and technical products” the activity on planning, organization of implementation and realization of the results of research works, which are performed to ensure fulfillment of Rostechnadzor’s authorities in the field of state regulation of safety at atomic energy use, is to be executed. The areas covered by the activity on production of scientific and technical products are as follows:

1) analysis of malfunctions and failures in operation of nuclear facilities;

2) development of scientific materials, which contain the results of studies and best practices in the field of nuclear and radiation safety regulation;

3) development of regulatory legal acts, regulatory & technical and guidance documents.

14.1. The main results of the activity on production of scientific and technical products include as follows: 

1) actuality, economic efficiency and perspective of the developed scientific and technical products, feasibility, thoroughness, practicality and executability of the obtained results;

2) compliance of the interim and final results of works with the requirements of the Technical Assignment and state-of-the-art;

3) application of the scientific and technical products in the course of substantiation of the nuclear and radiation safety principles and criteria, upgrading of the efficiency of the state regulation of nuclear and radiation safety at atomic energy use, planning and supervision, and at analysis of the results of the supervision activity.

14.2. Procedure of the process implementation is specified by:

1) The Federal Law No.127-FZ “On the Sciences and State Scientific and Technical Policy” dated of August 23, 1996;

2) The Federal Law No.44-FZ “On Contractual System in the Field of Purchasing of Products, Works, Services to Serve the State and Municipal Needs” dated of April 5, 2013;

3) “Provision on Assignment of a Legal Entity to Scientific and Technical Support Organization of the Authorized Body for State Regulation of Safety at Atomic Energy Use” enacted by the RF Government Decree No.387 dated of April 30, 2013;

4) The Rostechnadzor Order No.999 “On Arrangement of Planning in the Federal Environmental, Industrial and Nuclear Supervision Service” dated of November 9, 2006;

5) “Provision on Scientific and Technical Council of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.175 dated of March 20, 2007; 

6) “Provision on Arrangement of Works on Production of Scientific and Technical Products in the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.821 dated of November 30, 2007; 

7) The Rostechnadzor Order No.1185 “On Establishment of the Procedure for Elaboration of State Orders to the Federal State Enterprises Subordinating to the Federal Environmental, Industrial and Nuclear Supervision Service and Supervision over Execution thereof” dated of December 31, 2010. 

15. In frames of the process “Documentation management” the following actions are to be performed:

1) establishment of the system for provision of stakeholders with information on safety issues related to nuclear facilities, including regulation of nuclear and radiation safety at atomic energy use;

2) submission of regulatory legal acts on regulation of nuclear and radiation safety at atomic energy use to be published;

3) arrangement of publishing of regulatory & technical, information & reference and other required documentation.

15.1. The main results of the process include as follows:

1) publishing of proper quality documentation within the established dates;

2) creation of a full-text database of regulatory legal acts related to regulation of nuclear and radiation safety in the field of atomic energy use;

3) timely updating of the official website of Rostechnadzor and those of the subordinated scientific and technical support organizations;

4) provision of storage conditions for information of license applicants and (or) licensees in accordance with the requirements of the RF legislation.

15.2. The process implementation procedure is specified by:

1) “Provision on Access to Confidential Information of Restricted Use in the Federal Executive Authorities and Authorized Body for Control over Atomic Energy Use” enacted by the RF Government Decree No.1233 dated of November 3, 1994;

2) “Provision on Licensing of Activities in the Field of Atomic Energy Use” enacted by the RF Government Decree No.280 dated of March 29, 2013;

3) “Guidelines on the Procedure of Preparation to and Submission of Plans and Reports in the Field of International Cooperation of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechnadzor Order No.349 dated of June 2, 2005;

4) “Provision on the System of Information Protection in Computer or Telecommunication Networks of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.624 dated of June 26, 2006;

5) “Provision on Reporting to the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.954 dated of October 26, 2006;

6) “Standard Procedure on Protection of Information in Automated Means of the Headquarters, Territorial Departments and Organizations of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.873 dated of October 6, 2006;

7) The Rostechandzor Order No.999 “On Arrangement of Planning in the Federal Environmental, Industrial and Nuclear Supervision Service” dated of November 9, 2006;

8) “Instruction on the Procedure of Information Support of the Activity of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.927 dated of December 29, 2007;

9) “Regulations of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.271 dated of June 1, 2011;

10) “Instruction on Paperwork Management in the Headquarters of the Federal Environmental, Industrial and Nuclear Supervision Service” enacted by the Rostechandzor Order No.340 dated of June 30, 2011.

V. Allocation of functions and responsibilities of Rostechnador’s staff at implementation of QMS

16. Allocation of functions and responsibilities of staff in charge of the state regulation of safety at atomic energy use are to be specified by duty regulations.

17. The Chairman of Rostechnadzor ensures organization and coordination of development, implementation and correction of the Quality Policy, establishment, application, review and permanent enhancement of the QMS, bears primary responsibility for functioning of the QMS.

18. Deputy Chairmen of Rostechnadzor, Heads of Rostechnadzor Headquarter’s departments, Heads of Territorial Bodies, subordinated Scientific and technical support organizations bear responsibility within the limits of their competence for implementation of the Quality Policy. 

Direct executors are responsible for quality assurance of works performed.

19. Control over the quality of works performed is to be taken by Heads of the structural departments in frames of their competence. Based on the results of control actions measures are to be taken to eliminate and prevent non-conformances in the regulatory activity, or incentive measures are to take place.

20. In frames of each QMS process implemented in a certain department of Rostechnadzor, the structural departments are to provide the following:

1) effective interaction among the interrelated processes;

2) compliance of the documentation related to the process with the effective regulatory legal acts;

3) keeping of records required to verify the effectiveness of the processes;

4) control over implementation and enhancement of the process;

5) process compliance (including all amendments introduced) with the Quality Policy.